ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE

Wire, Guide, Catheter

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Hi-torque Extra S'port Guide Wire.

Pre-market Notification Details

Device IDK942066
510k NumberK942066
Device Name:ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara,  CA  95052 -8167
ContactJ.p. Palin
CorrespondentJ.p. Palin
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara,  CA  95052 -8167
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-29
Decision Date1994-07-18

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